Manual Lymphatic Drainage Versus Classical Massage on Heart Responses and Mood in Hemodialysis

Acute Effects of Manual Lymphatic Drainage and Classical Massage on Cardiovascular and Autonomic Responses and Mood in Patients Undergoing Hemodialysis: A Randomized Controlled Crossover Experimental Study

The goal of this randomized controlled crossover trial is to learn whether manual lymphatic drainage (MLD) and classical massage have different short-term effects on the heart, the nervous system, and mood in adults aged 18 to 65 receiving hemodialysis. A total of 60 patients from two hemodialysis centers in Tarsus, Mersin, Türkiye, are planned to take part.

The main questions it aims to answer are:

• Do MLD and classical massage differ in their short-term effects on autonomic nervous system responses, measured by heart rate variability (SDNN, RMSSD, LF, HF, LF/HF)? (Primary hypothesis 1)
• Do MLD and classical massage differ in their short-term effects on cardiovascular responses, measured by systolic and diastolic blood pressure and heart rate? (Primary hypothesis 2)
• Do MLD and classical massage differ in their short-term effects on mood (fatigue, vigor, tension, and confusion), measured by the Profile of Mood States - Short Form? (Secondary hypothesis)

Researchers will compare MLD with classical massage (active comparator). Each participant will receive both massages in a randomly assigned order (MLD first or classical massage first), so each participant serves as their own control. In addition, a no-massage control measurement will be taken in the week before the massages to show the changes caused by the hemodialysis session alone.

Participants will:

• In the first week (control period), have their blood pressure, heart rate, and heart rate variability measured three times during a hemodialysis session without any massage.
• In the second week, receive a 20-minute MLD or classical massage on both legs (thigh, lower leg, and foot), starting one hour after the beginning of the hemodialysis session.
• After a one-week break (washout period), receive the other type of massage in the same way.
• Have their blood pressure, heart rate, and heart rate variability measured before each massage, right after it, and 30 minutes later. Heart rate variability will be recorded for 5 minutes with a chest strap.
• Complete a short mood questionnaire.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Insufficiency, Chronic; Renal Dialysis; Massage; Manual Lymphatic Drainage; Affect (Mental Function)
• Intervention / Treatment: Other: Manual Lymphatic Drainage; Other: Classical Massage

Detailed Description

Cardiovascular disease is the leading cause of death in patients receiving hemodialysis (HD), accounting for about half of all deaths in this group. Blood pressure variability during dialysis is closely linked to cardiovascular events, and autonomic imbalance contributes to complications such as intradialytic hypotension and hypertension, each affecting about 15% of patients. Heart rate variability (HRV) is a non-invasive indicator of cardiac autonomic regulation and is reduced in chronic kidney disease. In addition, anxiety and depressive symptoms are common in HD patients and are associated with lower quality of life. Therefore, cardiovascular, autonomic, and emotional responses should be considered together during HD.

Massage is a low-cost, easy-to-apply, non-invasive nursing intervention with a low risk of serious side effects. Mechanical stimulation of the skin, muscle, and fascia may influence autonomic nervous system activity. Manual lymphatic drainage (MLD) is a technique that uses light, slow, rhythmic pressure to support lymphatic flow and has been associated with parasympathetic activation and relaxation. However, evidence on the cardiovascular and autonomic effects of MLD is limited, and its acute effects when applied during HD have not been studied.

Aim

The aim of this study is to evaluate and compare the acute cardiovascular, autonomic, and mood effects of 20-minute MLD and 20-minute classical massage applied during hemodialysis. The study is expected to help identify manual techniques that support cardiovascular and autonomic balance and to contribute to the development of evidence-based, non-pharmacological nursing interventions for HD care.

Originality

Previous massage studies in HD patients have mainly focused on symptoms and quality of life, such as fatigue, restless legs syndrome, muscle cramps, and sleep quality. Studies on the autonomic effects of MLD have mostly been conducted in healthy or stressed individuals. To the investigators' knowledge, no study has directly compared MLD and classical massage in terms of acute cardiovascular and autonomic responses in HD patients. This study is original in that:

• It evaluates HRV together with blood pressure and heart rate, allowing a multidimensional assessment of the acute physiological responses to two manual techniques during HD.
• It assesses acute changes in mood within a single dialysis session, whereas previous studies have focused on long-term psychological outcomes.
• It uses a crossover design in which each participant receives both interventions and serves as their own control, which reduces between-subject variability and increases statistical power.
• The interventions are applied during the dialysis session and can be integrated into routine care without adding extra time burden for patients.

Hypotheses

In hemodialysis patients, the effects of 20-minute MLD and 20-minute classical massage:

• Primary Hypothesis 1 (H1): differ in terms of acute autonomic responses (HRV).
• Primary Hypothesis 2 (H2): differ in terms of acute cardiovascular responses (systolic and diastolic blood pressure, heart rate).
• Secondary Hypothesis (H3): differ in terms of acute mood.

Methods

Design: Two-period, two-sequence (AB/BA), randomized controlled crossover study.

Participants: Patients aged 18 to 65 years who have received HD for at least three months, three times a week, about four hours per session. Main exclusion criteria are conditions preventing massage (e.g., foot ulcer, amputation, orthopedic problems), cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, lupus, diagnosed psychiatric illness, use of sleeping pills or sedatives, atrial fibrillation, and pacemaker use.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melike Davarci, BSN; Phone Number: +905326515093; Email: d.melike_2002@icloud.com

Study Locations

• Turkey (Türkiye)
  • Mersin
    • Mersin, Mersin, Turkey (Türkiye), 33343
      • Mersin University, Institute of Health Sciences
      • Contact: Melike Davarci; Phone Number: +905326515093; Email: d.melike_2002@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Being between 18 and 65 years of age
• Having received hemodialysis treatment for at least three months
• Receiving hemodialysis treatment at least three times a week, each session lasting approximately four hours
• Volunteering to participate in the study and providing written informed consent

Exclusion Criteria:

• Having a medical condition that would prevent the intervention, such as a foot ulcer, amputation, or an orthopedic problem
• Having a chronic disease such as cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, or lupus erythematosus
• Having been diagnosed with a psychiatric illness such as depression or bipolar disorder
• Having a history of a pathological condition, injury, or surgical procedure that would prevent the intervention from being performed safely
• Using sleeping pills or sedatives, as these may affect autonomic responses and HRV measurements
• Having a history of atrial fibrillation or having a pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MLD then Classical Massage (AB); Participants will undergo a no-intervention control measurement (Z0), then receive 20 minutes of manual lymphatic drainage on both lower extremities during hemodialysis in Period 1, and after a one-week washout period, 20 minutes of classical massage in Period 2.	Other: Manual Lymphatic Drainage; 20-minute MLD applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using light, slow, rhythmic, superficial stroking, pumping, circular, and rotary maneuvers directed toward the inguinal, popliteal, and medial malleolar lymphatic regions.; Other: Classical Massage; 20-minute classical massage applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using effleurage, petrissage, and friction, beginning and ending with effleurage.
Experimental: Classical Massage then MLD (BA); Participants will undergo a no-intervention control measurement (Z0), then receive 20 minutes of classical massage on both lower extremities during hemodialysis in Period 1, and after a one-week washout period, 20 minutes of manual lymphatic drainage in Period 2.	Other: Manual Lymphatic Drainage; 20-minute MLD applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using light, slow, rhythmic, superficial stroking, pumping, circular, and rotary maneuvers directed toward the inguinal, popliteal, and medial malleolar lymphatic regions.; Other: Classical Massage; 20-minute classical massage applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using effleurage, petrissage, and friction, beginning and ending with effleurage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Standard Deviation of Normal-to-Normal Intervals (SDNN)	Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Root Mean Square of Successive Differences (RMSSD)	Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Low Frequency (LF) Power	Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
High Frequency (HF) Power	Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Low Frequency to High Frequency Ratio (LF/HF)	Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Systolic Blood Pressure	Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Diastolic Blood Pressure	Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Heart Rate	Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

Secondary Outcome Measures

Outcome Measure	Time Frame
Fatigue Subscale Score of the Profile of Mood States - Short Form	Before and immediately after the 20-minute intervention, in each intervention period
Vigor Subscale Score of the Profile of Mood States - Short Form	Before and immediately after the 20-minute intervention, in each intervention period
Tension Subscale Score of the Profile of Mood States - Short Form	Before and immediately after the 20-minute intervention, in each intervention period
Confusion Subscale Score of the Profile of Mood States - Short Form	Before and immediately after the 20-minute intervention, in each intervention period

Collaborators and Investigators

• Sponsor: Mersin University

Study record dates

Study Major Dates

• Study Start (Estimated): November 24, 2026
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: November 6, 2026
• First Submitted That Met QC Criteria: November 6, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 6, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage; Drainage; Manual Lymphatic Drainage
• Other Study ID Numbers: 3715103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No